Ignite Creation Date:
2025-12-24 @ 7:52 PM
Ignite Modification Date:
2025-12-27 @ 7:53 AM
Study NCT ID:
NCT00746304
Status:
COMPLETED
Last Update Posted:
2008-09-03
First Post:
2008-08-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Long-Term Outcomes in the Treatment of Infantile and Acquired Esotropia With Botulinum Toxin
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004948', 'term': 'Esotropia'}], 'ancestors': [{'id': 'D013285', 'term': 'Strabismus'}, {'id': 'D015835', 'term': 'Ocular Motility Disorders'}, {'id': 'D003389', 'term': 'Cranial Nerve Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 164}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-09', 'completionDateStruct': {'date': '2007-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-08-31', 'studyFirstSubmitDate': '2008-08-31', 'studyFirstSubmitQcDate': '2008-08-31', 'lastUpdatePostDateStruct': {'date': '2008-09-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-09-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Degree of motor alignment, recurrence rate, incidence of stereopsis, and dissociated vertical deviation along with complications.', 'timeFrame': 'Before treatment, weekly after the treatment, and monthly after motor alignment'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['botulinum', 'esotropia'], 'conditions': ['Esotropia']}, 'descriptionModule': {'briefSummary': 'To investigate long-term treatment outcomes of patients receiving botulinum toxin A therapy for infantile and acquired esotropia.', 'detailedDescription': 'Participants: 164 patients with infantile esotropia and 89 patients with acquired esotropia.\n\nMethods: Patients were injected with botulinum toxin into two medial rectus muscles and followed from 1992 to 2005. Patients were evaluated at 1 week, 2, 6 and 12 months, and then yearly post-injection.\n\nMain Outcome Measures: Degree of motor alignment, recurrence rate, incidence of stereopsis, and dissociated vertical deviation along with complications.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '5 Years', 'minimumAge': '1 Day', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'A total of 373 patients with strabismus were treated with botulinum toxin injection by a single surgeon (AH Wang) at the Department of Ophthalmology, National Taiwan University Hospital, Taipei, Taiwan from 1992 to 2005.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* infantile esotropia and acquired esotropia\n\nExclusion Criteria:\n\n* exotropia, high AC/A ratio accommodative esotropia, patients with neurological deficit including cerebral palsy, Down syndrome and mental retardation, and ocular anomalies including retinopathy of prematurity. Patients lost to follow-up at 6 months or less after the last injection were also excluded.'}, 'identificationModule': {'nctId': 'NCT00746304', 'briefTitle': 'Long-Term Outcomes in the Treatment of Infantile and Acquired Esotropia With Botulinum Toxin', 'organization': {'class': 'OTHER', 'fullName': 'National Taiwan University Hospital'}, 'officialTitle': 'Long-Term Outcomes in the Treatment of Infantile and Acquired Esotropia With Botulinum Toxin', 'orgStudyIdInfo': {'id': '200709002R'}}, 'armsInterventionsModule': {'armGroups': [{'label': '1', 'description': 'infantile esotropia'}, {'label': '2', 'description': 'acquired esotropia'}]}, 'contactsLocationsModule': {'locations': [{'zip': '100', 'city': 'Taipei', 'country': 'Taiwan', 'facility': 'National Taiwan University Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}], 'overallOfficials': [{'name': 'Tzu-Hsun Tsai, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Taiwan University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Taiwan University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Tsai Tzu-Hsun', 'oldOrganization': 'National Taiwan University Hospital'}}}}